Roche challenges Regeneron and Bayer’s position as industry leaders within wAMD, DME and DR spaces, says GlobalData

10 May, 2024 Roche challenges Regeneron and Bayer's position as industry leaders within wAMD, DME and DR spaces, says GlobalData

Posted in Pharma

Roche's Vabysmo (faricimab) is in the spotlight following its promising Q1 2024 sales figures. Vabysmo, a vascular endothelial growth factor (VEGF) inibitior and angiopoietin-2 (Ang-2) inhibitor therapy, is indicated for wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). This presents a looming challenge to Regeneron and Bayer's high-dose Eylea (Eylea HD) (aflibercept 8mg), a VEGF inhibitor, which recently entered the DME, wAMD, and diabetic retinopathy (DR) spaces in the US, says GlobalData, a leading data and analytics company.

Vabysmo, which gained FDA approval in January 2022, had sales of $927 million in Q1 2024.

In GlobalData's Age-Related Macular Degeneration: Seven-Market Drug Forecast and Market Analysis - Update, and Diabetic Macular Edema: Seven-Market Drug Forecast and Market Analysis Update reports, the sales of Vabysmo for 2024 were forecast to reach $3.3 billion across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan). While Regeneron and Bayer have not yet released their sales figures for Q1, in February they reported that over the previous four months, Eylea HD had sales of $166 million in the US. However, the sales of Eylea in the US fell from $6.3 billion in 2022 to $5.9 billion in 2023.

Sara Reci, MSc, Senior Pharma Analyst at GlobalData, comments: "The launch of Eylea HD is anticipated to impact Vabysmo sales, with primary research with key opinion leaders (KOLs) indicating that Eylea HD's durability was on par or better than Vabysmo."

Nonetheless, a meta-analysis study comparing seven trials of Eylea and Vabysmo, which is set to be presented this week at the Annual Scientific Meeting of the Association for Research in Vision and Ophthalmology in Seattle, revealed that in AMD and DME patients, a greater reduction in central subfield thickness was observed with Vabysmo. However, another contributing factor to the comparatively lower sales of Eylea HD could also be the fact that until 01 April, Eylea HD lacked a permanent J-code-an identifying system that is essential for the billing of medications and reimbursement of drugs, and which may have hampered its prescription.

The KOLs interviewed by GlobalData noted that "a lot of the durability that you see with the high-dose aflibercept seems to be on par with that which you see with VABYSMO. So I think that it's probably comparable to that. Now, you're just getting, it's basically super suppression of VEGF as opposed to a dual molecule." Another KOL added that the "durability in the pivotal study seems to be better for aflibercept 8 milligrams in comparison to Vabysmo, but the inclusion criteria and the exclusion criteria were different in both of these. So it's not really comparable."

Thus, the results of the meta-analysis mentioned by Roche are highly anticipated, given the difficulty in comparing trials for Vabysmo and Eylea HD. In addition to the company's successful start to 2024 with Vabysmo's sales, Roche is taking extra measures to further establish itself within the wAMD, DME, and DR space. It plans to re-launch Susvimo for wAMD in Q3, which was formerly voluntarily recalled due to leakage issues, as well as filing for DME and DR as new indications for Susvimo in H2 2024.

Reci concludes: "If Roche's Vabysmo continues to provide promising sales figures for the foreseeable future, in addition to the company's anticipated re-launch of Susvimo and Suvsimo's label expansion, Roche will have put itself on track to becoming an industry leader within the ophthalmological space."